Postmarket Requirements for Medical Devices: A Practical Guide
37
replacing parts at the end of their normal
life expectancy, e.g., calibration, battery
replacements, and responses to normal wear
and tear. Repairs of an unexpected nature,
replacing parts earlier than their normal life
expectancy, or identical repairs or replace-
ments of multiple units of a device are not
routine servicing.
• “Stock recovery” is defined as a firm’s
removal or correction of a product that
has not been marketed or that has not left
the firm’s direct control, i.e., the product is
located on premises owned by, or under the
control of, the firm, and no portion of the lot
has been released for sale or use.
Under 21 CFR 7.3, FDA classifies recalls into
three numerical designations for a particular
product based on the probability and severity of
health consequences. Once a firm opts to correct
or remove a violative product, a correction or
removal action plan is submitted to FDA. FDA
is responsible for reviewing the recall strategy
and assessing the health hazard presented by the
defective or harmful medical device and decid-
ing whether the problem violates FDA laws and
requirements.
FDA conducts a Health Hazard Evaluation
(HHE) to determine the risks posed by a device
and actions taken by a firm to resolve them.
HHE is a critical tool for classifying a volun-
tary recall by a firm. An FDA physician may
initiate an HHE by collecting and reviewing
information such as adverse events, complaints,
and problems related to the defective or harmful
device. A few factors taken into consideration
that are suitable for HHE include but are not
limited to the following:36
• Diseases or injuries occurred from the use of
the product
• Assessment of exposure of a hazard to
various groups, such as pediatric, surgical
patients, pets, livestock, etc.
• Assessment of the hazard’s likelihood of
occurrence
• Assessment of the hazard’s consequences
(immediate or long term) of occurrence
Based on the HHE determination, recalls are
classified into three categories, as listed in
Table 2-4.
Recall Procedure
Any medical device not meeting the defined
quality standards must be recalled from the
market. Recalls can be classified into two types:
1) voluntary recall and 2) mandatory recall
(initiated by FDA). As soon as the product to
be recalled is identified, the following steps are
taken after the recall is initiated:
Step 1—Recall Strategy: Once FDA deter-
mines that the product is violative, a correction or
removal will be considered as a recall per 21 CFR
7.46.37 Recall applications should be submitted
to FDA with the following information:
Table 2-4. Types of FDA Recalls35
Type of
Recall Criteria Examples
Class I A scenario where there is a possibility of occurrence
of serious health adverse consequences or death in
case of exposure to or use of a violative product
A scenario in which a catheter may rupture or kink
during use, leaving remnants behind in the patient
that will cause serious injuries or death
Class II A scenario where there is a possibility of occurrence
of temporary or medically reversible health
consequences or where the probability of serious
adverse health consequences is remote in case of
exposure to or use of a violative product
A package defect in which sterility has been
compromised and could lead to contamination
of the medical device, resulting in patient
complications
Class III A scenario where the exposure to or use of a
violative product is not likely to cause adverse health
consequences
A mislabeled package where the expiration date
does not appear on the product label or instructions
for use (IFU)
37
replacing parts at the end of their normal
life expectancy, e.g., calibration, battery
replacements, and responses to normal wear
and tear. Repairs of an unexpected nature,
replacing parts earlier than their normal life
expectancy, or identical repairs or replace-
ments of multiple units of a device are not
routine servicing.
• “Stock recovery” is defined as a firm’s
removal or correction of a product that
has not been marketed or that has not left
the firm’s direct control, i.e., the product is
located on premises owned by, or under the
control of, the firm, and no portion of the lot
has been released for sale or use.
Under 21 CFR 7.3, FDA classifies recalls into
three numerical designations for a particular
product based on the probability and severity of
health consequences. Once a firm opts to correct
or remove a violative product, a correction or
removal action plan is submitted to FDA. FDA
is responsible for reviewing the recall strategy
and assessing the health hazard presented by the
defective or harmful medical device and decid-
ing whether the problem violates FDA laws and
requirements.
FDA conducts a Health Hazard Evaluation
(HHE) to determine the risks posed by a device
and actions taken by a firm to resolve them.
HHE is a critical tool for classifying a volun-
tary recall by a firm. An FDA physician may
initiate an HHE by collecting and reviewing
information such as adverse events, complaints,
and problems related to the defective or harmful
device. A few factors taken into consideration
that are suitable for HHE include but are not
limited to the following:36
• Diseases or injuries occurred from the use of
the product
• Assessment of exposure of a hazard to
various groups, such as pediatric, surgical
patients, pets, livestock, etc.
• Assessment of the hazard’s likelihood of
occurrence
• Assessment of the hazard’s consequences
(immediate or long term) of occurrence
Based on the HHE determination, recalls are
classified into three categories, as listed in
Table 2-4.
Recall Procedure
Any medical device not meeting the defined
quality standards must be recalled from the
market. Recalls can be classified into two types:
1) voluntary recall and 2) mandatory recall
(initiated by FDA). As soon as the product to
be recalled is identified, the following steps are
taken after the recall is initiated:
Step 1—Recall Strategy: Once FDA deter-
mines that the product is violative, a correction or
removal will be considered as a recall per 21 CFR
7.46.37 Recall applications should be submitted
to FDA with the following information:
Table 2-4. Types of FDA Recalls35
Type of
Recall Criteria Examples
Class I A scenario where there is a possibility of occurrence
of serious health adverse consequences or death in
case of exposure to or use of a violative product
A scenario in which a catheter may rupture or kink
during use, leaving remnants behind in the patient
that will cause serious injuries or death
Class II A scenario where there is a possibility of occurrence
of temporary or medically reversible health
consequences or where the probability of serious
adverse health consequences is remote in case of
exposure to or use of a violative product
A package defect in which sterility has been
compromised and could lead to contamination
of the medical device, resulting in patient
complications
Class III A scenario where the exposure to or use of a
violative product is not likely to cause adverse health
consequences
A mislabeled package where the expiration date
does not appear on the product label or instructions
for use (IFU)